Device Classification Name |
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
|
510(k) Number |
K034009 |
Device Name |
LAPEX 2000 |
Applicant |
MERIDIAN CO., LTD. |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
MERIDIAN CO., LTD. |
PO BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 12/24/2003 |
Decision Date | 01/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|